MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA PEDICLE SCREW MIS ROD INSERT - ANGLED; SURGICAL INSTRUMENT FOR SPINE

Catalog Number	03.52.10.0420
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	05/15/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Batch review performed on 07 jun 2019.Lot 1850291: (b)(4) items manufactured and released on (b)(4) 2018.No anomalies found related to the problem.To date, no similar events have been reported on this lot.Visual inspection performed by r&d project manager: the instrument is intended to insert in correct position the rod.Due to some difficults during the removal of the instrument from the rod, probably due to contact between the instrument and the bone, the surgeon hammered the rod inserter causing the breakage of the welding and the consequent accidental loss of the tip of the instrument.The part of the instrument is made of bio-compatible material (stainless steel per astm f899 and iso 16061) and is radiopaque therefore it would be seen in the x-ray images routinely taken during the procedure.In the set is present a second rod inserter so that the surgeon can conclude the surgery without wasting time.
Event or Problem Description
During the spine mis surgery it was difficult to disengage the rod holder from the rod (tip blocked on the rod).The surgeon tried to pull it out without success.He used also an hammer to force the part and the instrument broke.It was not possible to disassemble the instrument tip from the rod so the surgeon had to perform an additional cut to remove the instrument part.The surgery was completed successfully but 1 hour of delay experienced in the surgery and an additional cut necessary.

• Brand Name: PEDICLE SCREW MIS ROD INSERT - ANGLED
• Common Device Name: SURGICAL INSTRUMENT FOR SPINE
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 8695293
• Report Number: 3005180920-2019-00465
• Device Sequence Number: 1644165
• Product Code: LXH
• UDI-Device Identifier: 07630971202665
• UDI-Public: 07630971202665
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 06/13/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 03.52.10.0420
• Device Lot Number: 1850291
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/28/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/15/2019
• Initial Report FDA Received Date: 06/13/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other